NAC585.270. Qualifications of personnel.

     1. The personnel who are responsible for directing the manufacture and control of a drug must be adequate in number and have sufficient education, training and experience, or a combination thereof, to ensure that the drug will have the safety, identity, strength, quality and purity that it is purported or represented to possess.

     2. All personnel must have:

     (a) Capabilities commensurate with their assigned functions;

     (b) A thorough understanding of the manufacturing or control operations which they perform;

     (c) The necessary training or experience; and

     (d) Adequate information concerning the reasons for the application of the pertinent provisions of this chapter to their respective functions.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 2.3 & 2.3.1, eff. 5-15-78]—(NAC A 9-17-82)